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FDA 510(k)

Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold

K-Number: K173023 · 2017-11-17

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2017-11-17
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2017-11-17 under approval number K173023. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold?

Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold is a medical device that received FDA 510(k) clearance on 2017-11-17. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K173023.

When was Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold approved by the FDA?

Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold received FDA 510(k) clearance on 2017-11-17, under approval number K173023.

What company makes Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold?

Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold?

The FDA product code for Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold is KPS.

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Related Devices (Code: KPS)

K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc. K161674QuantumCamDdd-Diagnostic A/S K162337Symbia 6.5Siemens Medical Solutions USA, Inc. K161574Discovery MIGe Medical Systems, LLC K161631MAMMIGeneral Equipment For Medical Imaging

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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